MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICROBORE TRI-FUSE EXTENSION SET, 3 IV C; INTRAVASCULAR ADMINISTRATION SET

Model Number MZ9266

Device Problems Backflow (1064); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one used extension set, model mz9266, was received by the customer for investigation.A non-bd codan extension set was received as well.Upon visual inspection, dried residue was noted in 2 of the three maxzeros.No defects were visually observed.The sample was functionally tested and no leaks or backflow was seen.The customer's complaint of the maxzero leaking and dopamine was backing up to the syringe could not be verified.No syringe was returned so the syringe/ maxzero connection could not be tested.A device history record review could not be performed on model mz9266 because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that dopamine leaked from the microbore tri-fuse extension set, 3 iv c and backed up into the syringe.The following information was provided by the initial reporter: "maxzero leaking and dopamine backing up to the syringe.This includes the complete set-up in the nicu.".

• Brand Name: MICROBORE TRI-FUSE EXTENSION SET, 3 IV C
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12200409
• MDR Text Key: 262661344
• Report Number: 9616066-2021-51570
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403240780
• UDI-Public: 50885403240780
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MZ9266
• Device Catalogue Number: MZ9266
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1